FDA Adverse Event
Injury
Summary report: N
MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
MDR report key: 3872526
·
Received June 26, 2014
Report
- Report Number
- 9710014-2014-00291
- Event Type
- Injury
- Date Received
- June 26, 2014
- Date of Event
- May 23, 2014
- Report Date
- June 4, 2014
- Manufacturer
- MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
- Product Code
- MCM
- PMA / PMN Number
- P000025
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN EXPLANTED AND SHOULD BE RETURNED TO THE MFR FOR EVALUATION. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A FOLLOW UP REPORT.
Description of Event or Problem · 1
AN X-RAY PERFORMED ON (B)(6), 2014 SHOWED THAT THE ELECTRODE ARRAY HAD BEEN INSERTED INTO THE VESTIBULE OF THE COCHLEA. THE PATIENT WAS RE-IMPLANTED ON (B)(6), 2014.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 373923 | MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM | MED-EL CONCERT +FLEX 28 | MCM | MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Required Intervention |